Policy Template - Mohawk College Research Ethics Board

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Policy Template

Policy Number: AS- 2100 -2013

Policy Title: Mohawk College Research Ethics Board

Policy Owner: Vice President, Academic

Effective Date: July 15, 2013

1.

Purpose:

Mohawk College recognizes the value of ethical research integrity as it applies to research to be conducted under the auspices of Mohawk College.

This policy supports the establishment of an independent REB that has the authority and mandate to review “ethical acceptability of research” (TCPS2, p. 69) on behalf of Mohawk

College and is compliant with the Tri-Council Policy Statement: Ethical Conduct for

Research Involving Humans, (TCPS2, December 2010). http://www.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf

The TCPS2 is a joint policy of the Canadian Institutes of Health Research (CIHR), the

Natural Sciences and Engineering Research Council (NSERC), and the Social Sciences and

Humanities Research Council (SSHRC).

The TCPS2, updated in December 2010, describes the principles and procedures that govern research conducted with humans. It is essential for researchers to follow the TCPS2 to qualify for research funds through the CIHR, NSERC and SSHRC federal grant agencies.

To ensure that all research conducted at Mohawk College by faculty, staff, students and the research community at large, meets the following research ethical principles:

 Requirement for free and informed consent

 Respect for vulnerable persons

 Respect for privacy and confidentiality

 Respect for justice and inclusiveness

 Balancing harms and benefits

 Minimizing harm

 Maximizing benefit

Mohawk College’s Research Ethics Board (MCREB) is governed by the policies outlined in this document. This policy supports the delegation of authority to the MCREB to review the “ethical acceptability of research” (TCPS2 p.69) including approving, rejecting or proposing modifications to research applications on behalf of Mohawk

College.

2.

Application and Scope

This policy will apply to all research involving humans conducted at or under the auspices of Mohawk College. This will include staff in the Academic and Support Staff bargaining units, sessional and part time staff, administrative staff, consultants, students conducting research as a requirement in their academic program and all other persons (researchers) conducting research at and/or under the auspices of Mohawk College.

The MCREB will review all research proposals following the TCPS2 and will be approved by the MCREB prior to conducting research.

2.1 MCREB Terms of Reference

Responsibility

The MCREB is responsible for ensuring the safety and rights of all research participants at Mohawk College. The MCREB will:

 Assess and limit risks to participants in research involving humans

 respect a person’s right to autonomy, self-determination and dignity

 ensure that all research involving human participants and conducted within or on behalf of Mohawk College, reflects high standard of ethical values

 ensures that protocols are maintained in accordance to College policies and standards, and provincial and federal legislation

 develops guidelines and policy recommendations regarding ethical conduct of research conducted at Mohawk College and all affiliated sites

 serve as a consultative entity contributing to education in research and ethics

This responsibility is also shared by the researcher.

Authority

The MCREB reviews all applications for research activities involving human participants at and/or under the auspices of Mohawk College.

The MCREB has the responsibility and authority to approve, reject, propose modifications, to, or terminate any proposed or ongoing research involving human subjects.

MCREB deliberations are independent of the organization’s reporting structure. The

MCREB also supports faculty, staff and students of Mohawk College, as a consultative entity, by contributing to education in research ethics involving humans.

Mohawk College will ensure that the MCREB receives appropriate financial and administrative independence to fulfill the mandate of ethical review of proposed research applications.

3.

Definitions

Core principles: the three core principles of TCPS2 express the overarching value of respect for human dignity: respect for persons, concern for welfare and justice

REB: researchers, community members, and others with specific expertise established by an institution to review the ethical acceptability of all research involving humans within the institution’s jurisdiction or under the auspices of the institution

4.

Principles

The MCREB will follow the three guiding principles:

Respect for Persons

“…recognizes the intrinsic value of human beings and the respect and consideration that they are due”. (TCPS2, December 2010, p.8).

Concern for Welfare

Welfare includes physical, mental, spiritual, economic and social well- being. In addition, welfare includes privacy and control of personal information. REBs should aim to protect the welfare of participants by ensuring that participants have adequate information to make an informed decision about research participation. (TCPS2,

December 2010, p.9).

Justice

To ensure that all research participants are treated fairly and equitably. In recognizing differences in vulnerability levels, the REB will ensure that the these differences are respected and mitigated in research studies with extra consideration given to the planning and conducting of research to ensure the principle of justice is demonstrated.

(TCPS2, December 2010, p.10).

5.

Accountability and Compliance

The MCREB is responsible for and oversees the ethical review and practice of research involving humans at the College by ensuring and monitoring compliance with TCPS2; submits an annual report to the Vice President, Academic.

5.1 Accountability

This policy will be administered by the MCREB.

The MCREB will: o meet regularly to fulfill the terms of reference, maintain minutes and documentation o The MCREB Chair and Research Ethics Co-ordinator is responsible for the administration of the day to day operations of the MCREB o Keep Vice President, Academic informed of substantive issues in regards to policy, process and compliance; and submit an annual report

5.2 Compliance

With the establishment of an independent REB, this policy will ensure compliance with and support of ethical research principles to be eligible to receive and sustain research funding.

5.3 MCREB Member Conflict of Interest

MCREB members shall disclose real, perceived conflicts of interest to the MCREB.

When necessary, the MCREB may decide that some of its members must withdraw from

MCREB deliberations and decisions.

5.4 Record Keeping of MCREB Documents

The MCREB shall prepare and maintain comprehensive records, including all documentation related to the projects submitted to the MCREB for review, attendance at all MCREB meetings, and accurate minutes reflecting MCREB decisions. Where the

MCREB denies ethics approval for a research proposal, the minutes shall include the reasons for this decision.

6.

Rules

6.1 MCREB Membership

The MCREB membership and terms of reference will be in accordance with TCPS2

(TCPS2, December 2010, 6.4):

The MCREB will consist of at least five members, including both men and women, of whom:

 At least two members have expertise in relevant research disciplines, fields and methodologies covered by the MCREB;

 At least one member is knowledgeable in ethics;

 At least one member is knowledgeable in the relevant law (but that member should not be the institution’s legal counsel or risk manager). This is mandatory for

biomedical research and is advisable, but not mandatory, for other areas of research; and

 At least one community member who has no affiliation with the institution

It is advisable that each member be appointed to formally fulfill the requirements of only one of the above categories. To ensure the independence of MCREB decision making, institutional senior administrators shall not serve on the MCREB.

6.2 Terms of Appointment/Meetings and Attendance

The term of office for the MCREB Chair and MCREB members will be three years. The

MCREB Chair will be elected by the committee every three years. The MCREB Chair and members may be re-elected for second term, however, membership will be reviewed annually with the goal to recruit two members each year. Rotation of MCREB membership will reflect the diversity of opinion and provide the opportunity to advance knowledge and expertise gained from MCREB membership.

MCREB members will receive an orientation upon appointment. All MCREB members will be required to complete the TCPS2 Core Training online tutorial within three (3) months of appointment.

MCREB members will meet annually for professional development. The MCREB Chair and/or at least one member will attend the annual CAREB conference and regional professional development opportunities.

The MCREB will meet monthly during September – June.

A quorum for MCREB committee meetings is 50% plus one member present.

6.3 MCREB Chair

The MCREB Chair is responsible for ensuring that the REB process complies with the

TCPS2 Policy Statement. The MCREB Chair will provide overall leadership for the

MCREB and facilitate the REB review processed based on institutional policies and procedures and the TCPS2. The MCREB Chair will monitor the MCREB’s decisions for consistency and to ensure that all decisions are documented and communicated clearly to researchers in a timely manner.

7.

Policy Revision Date

Reviewed every three (3) years

Vice President, Academic

8.

Specific Links

This policy was compiled with extensive references to the Tri-Council Policy Statement:

Ethical Conduct of Research Involving Humans, December, 2010 http://www.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf

In addition, review and consultation to other institution’s Research Ethics Board policies including but not limited to: Centennial College, Sheridan College, Conestoga College, McMaster

University, was completed.

Canadian Association of Research Ethics Boards http://www.careb-accer.or

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